Home NDC 72507-800 FORZINITY
Product NDC 72507-800
11-digit product format 725070800
Labeler code 72507
Product ID 72507-800_459e2433-fbbb-2cef-e063-6394a90a81fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Elamipretide Hydrochloride
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Stealth Biotherapeutics Inc.
Application NDA215244
Marketing category NDA
Marketing start 2025-10-30
Substance ELAMIPRETIDE HYDROCHLORIDE
Active strength 280 mg/3.5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215244-001 FORZINITY ELAMIPRETIDE HYDROCHLORIDE EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215244-001 7576061 2027-01-20 Drug substance, Drug product 2025-10-14 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 N215244-001 9687519 2034-02-28 U-4277 2025-10-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215244-001 NCE 2030-09-19 N215244-001 ODE-551 2032-09-19
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215244-001 FORZINITY EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215244-001 FORZINITY EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215244-001 FORZINITY EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 FORZINITY EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 FORZINITY EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-09-19 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215244-001 7576061 2027-01-20 Drug substance, Drug product 2025-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215244-001 9687519 2034-02-28 U-4277 2025-10-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215244-001 7576061 2027-01-20 Drug substance, Drug product 2025-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215244-001 9687519 2034-02-28 U-4277 2025-10-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215244-001 7576061 2027-01-20 Drug substance, Drug product 2025-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215244-001 9687519 2034-02-28 U-4277 2025-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 7576061 2026-01-20 Drug substance, Drug product 2025-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215244-001 9687519 2034-02-28 U-4277 2025-10-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 7576061 2027-01-20 Drug substance, Drug product 2025-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 11083771 2034-02-28 U-4277 2025-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 11083772 2034-02-28 U-4277 2025-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 11771734 2034-02-28 U-4277 2025-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 12268724 2034-02-28 U-4277 2025-10-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215244-001 9687519 2034-02-28 U-4277 2025-10-14 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base FORZINITY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELAMIPRETIDE HYDROCHLORIDE 280 mg/3.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E40WZ3BK2D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2725604 Internal RxNorm lookup 2725610 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72507-800-04 FORZINITY 4 in 1 CARTON INJECTION 4 10 72507-800-30 FORZINITY 3.5 mL in 1 VIAL INJECTION 3.5 10
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FORZINITY ELAMIPRETIDE HYDROCHLORIDE Stealth Biotherapeutics Inc. 146bf34c-76f2-48db-ac07-fb29cce2cd75 2025-12-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 215244 application number: NDA215244 ndc (product): 72507-800
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72507-800-04 72507080004 4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30) 4 vial 2025-10-30 No No Current 72507-800-30 72507080030 3.5 mL in 1 VIAL 3.5 ml Historical